Capitainer 启动 HbA1c FDA 510(k) 研究临床采样
Capitainer Initiates Clinical Sampling for HbA1c FDA 510(k) Study
Capitainer 已采集 HbA1c FDA 510(k) 注册研究首例临床样本，研究计划纳入至少 120 名参与者，评估使用 Capitainer®B50 自采样与辅助毛细血管采血，并与传统静脉血样本的 HbA1c 结果对比。
, /PRNewswire/ -- Capitainer, a Swedish provider of volumetric microsampling solutions, has reached an important milestone in its U.S. regulatory strategy with the first clinical sample collected as part of its study on HbA1c, a marker of long-term blood glucose levels, intended to support a planned FDA 510(k) submission.
The study is expected to include at least 120 participants and will evaluate both self-sampling and assisted capillary blood collection using Capitainer®B50. HbA1c results will be compared against those obtained from conventional venous blood samples. The samples collected during the study will be analyzed by Three Rivers Diagnostics and Aegis Sciences Corporation using laboratory instrumentation from Roche. Data collection is expected to be completed in November 2026.
"Reaching this milestone is an important step in our continued development in the U.S. market. We see significant opportunities for microsampling technology to support more accessible blood testing and help healthcare providers address gaps in care. This study represents an important part of our long-term strategy to expand the clinical applications of our technology," says Christopher Aulin, CEO of Capitainer.
About
Capitainer AB is a Swedish MedTech company that develops and sells patient-centric solutions for self-sampling of blood, plasma, and urine. Founded in 2016, Capitainer has developed unique technologies for collecting and drying exact volumes of fluid within easy-to-use sampling cards. These cards may be sent as standard post to relevant testing laboratories, thus bypassing the need for cold chain logistics and specialized packaging. Capitainer's products are market-leading with respect to precision and accuracy, with demonstrated equal performance to established pipetting methods. The products are applicable within several market segments, including but not limited to, clinical biomarkers, therapeutic drug monitoring, genomics, drug abuse and doping testing, and R&D and clinical studies.
Capitainer®B50 is FDA-listed as a Class I in vitro diagnostic (IVD) device. Its use for HbA1c testing is currently under clinical investigation and has not received FDA clearance for this application.
SOURCE Capitainer AB
来源：PR Newswire Health · prnewswire.com